FDA ARMAT Status for Affimed and Artiva's Lymphoma Therapy

Affimed and Artiva Biotherapeutics’ combination therapy for lymphoma has received regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA). This therapy incorporates Artiva’s AlloNK (AB101) and Affimed’s acimtamig (AFM13), an innate cell engager, to treat relapsed or refractory Hodgkin’s lymphoma (R/R HL).

Currently, the safety and efficacy of this therapy are being evaluated through the multi-centre, multi-cohort Phase II LuminICE-203 trial. Earlier in 2024, Affimed shared promising early efficacy data from the first two cohorts of the trial, which included 12 subjects. Results revealed a well-managed safety profile, an overall response rate of 83.3%, and a complete response rate of 50%.

Dr. Shawn Leland, CEO of Affimed, emphasized the significance of the regulatory milestone, highlighting that the FDA recognizes the urgent need for new therapies for R/R HL, especially for double refractory HL patients who lack approved treatment options. He stated that the RMAT designation not only underlines the robustness of their clinical data but also signifies the potential of their innovative treatment to offer hope to patients struggling with this challenging cancer.

Acimtamig, as a first-in-class innate cell engager, activates the innate immune system to target and destroy CD30-positive hematologic tumors. It functions by engaging and activating natural killer cells and macrophages, which subsequently leads to the selective destruction of CD30-positive tumor cells.

The RMAT designation, designed to expedite the development of regenerative medicine therapies for severe or life-threatening conditions, offers advantages similar to a breakthrough therapy designation but is specifically intended for regenerative medicine products. This designation provides Affimed with enhanced access to FDA resources, including the potential for accelerated approval and priority review.

Additionally, in August 2023, the FDA approved Artiva's AlloNK (AB-101) and rituximab combination's investigational new drug application. This approval aims to address systemic lupus erythematosus in individuals with active lupus nephritis.